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Research ArticleINTERVENTIONAL

The FRESH Study: Treatment of Intracranial Aneurysms with the New FRED X Flow Diverter with Antithrombotic Surface Treatment Technology—First Multicenter Experience in 161 Patients

D.F. Vollherbst, H. Lücking, J. DuPlessis, M. Sonnberger, C. Maurer, N. Kocer, M. Killer-Oberpfalzer, R. Rautio, L. Valvassori, A. Berlis, S. Gasser, S. Gatt, A. Dörfler, M. Bendszus and M.A. Möhlenbruch
American Journal of Neuroradiology March 2023, DOI: https://doi.org/10.3174/ajnr.A7834
D.F. Vollherbst
aFrom the Department of Neuroradiology (D.F.V., M.B., M.A.M.), Heidelberg University Hospital, Heidelberg, Germany
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  • ORCID record for D.F. Vollherbst
H. Lücking
bDepartment of Neuroradiology (H.L., A.D.), University of Erlangen-Nuremberg, Erlangen, Germany
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J. DuPlessis
cDepartment of Clinical Neurosciences (J.D., S. Gatt), Royal Infirmary of Edinburgh, Edinburgh, UK
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M. Sonnberger
dDepartment of Neuroradiology (M.S., S. Gasser), Johannes Kepler University Linz, Linz, Austria
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C. Maurer
eDepartment of Diagnostic and Interventional Neuroradiology (C.M., A.B.), University Hospital Augsburg, Augsburg, Germany
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N. Kocer
fDepartment of Radiology (N.K.), Division of Neuroradiology, Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Istanbul, Turkey
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M. Killer-Oberpfalzer
gDepartment of Neurology (M.K.-O.), Institute of Neurointervention, Paracelsus Medizinische Privatuniversität, Salzburg, Austria
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R. Rautio
hDepartment of Interventional Radiology (R.R.), Turku University Hospital, Turku, Finland
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L. Valvassori
iDepartment of Neuroradiology (L.V.), San Carlo Borromeo Hospital, Milano, Lombardia, Italy
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A. Berlis
eDepartment of Diagnostic and Interventional Neuroradiology (C.M., A.B.), University Hospital Augsburg, Augsburg, Germany
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S. Gasser
dDepartment of Neuroradiology (M.S., S. Gasser), Johannes Kepler University Linz, Linz, Austria
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S. Gatt
cDepartment of Clinical Neurosciences (J.D., S. Gatt), Royal Infirmary of Edinburgh, Edinburgh, UK
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A. Dörfler
bDepartment of Neuroradiology (H.L., A.D.), University of Erlangen-Nuremberg, Erlangen, Germany
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M. Bendszus
aFrom the Department of Neuroradiology (D.F.V., M.B., M.A.M.), Heidelberg University Hospital, Heidelberg, Germany
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M.A. Möhlenbruch
aFrom the Department of Neuroradiology (D.F.V., M.B., M.A.M.), Heidelberg University Hospital, Heidelberg, Germany
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Abstract

BACKGROUND AND PURPOSE: Flow diverters with antithrombotic coatings are increasingly used to improve the safety of flow diverter treatments of intracranial aneurysms. This study aimed to investigate the safety and short-term efficacy of the new FRED X flow diverter.

MATERIALS AND METHODS: Medical charts and procedural and imaging data of a consecutive series of patients with intracranial aneurysms who were treated with the FRED X at 9 international neurovascular centers were retrospectively analyzed.

RESULTS: One hundred sixty-one patients (77.6% women; mean age, 55 years) with 184 aneurysms (11.2% acutely ruptured) were included in this study. Most aneurysms were located in the anterior circulation (77.0%), most frequently at the ICA (72.7%). The FRED X was successfully implanted in all procedures. Additional coiling was performed in 29.8%. In-stent balloon angioplasty was necessary in 2.5%. The rate of major adverse events was 3.1%. Thrombotic events occurred in 7 patients (4.3%) with 4 intra- and 4 postprocedural in-stent thromboses, respectively (1 patient had both peri- and postprocedural thrombosis). Of these thrombotic events, only 2 (1.2%) led to major adverse events (ischemic strokes). Postinterventional neurologic morbidity and mortality were observed in 1.9% and 1.2%, respectively. The rate of complete aneurysm occlusion after a mean follow-up of 7.0 months was 66.0%.

CONCLUSIONS: The new FRED X is a safe and feasible device for aneurysm treatment. In this retrospective multicenter study, the rate of thrombotic complications was low, and the short-term occlusion rates are satisfactory.

ABBREVIATIONS:

ASA
acetylsalicylic acid
BA
basilar artery
FD
flow diverter
HH
Hunt and Hess
OKM
O’Kelly-Marotta
PcomA
posterior communicating artery
RROC
Raymond-Roy occlusion classification

Footnotes

  • Disclosure forms provided by the authors are available with the full text and PDF of this article at www.ajnr.org.

  • © 2023 by American Journal of Neuroradiology
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The FRESH Study: Treatment of Intracranial Aneurysms with the New FRED X Flow Diverter with Antithrombotic Surface Treatment Technology—First Multicenter Experience in 161 Patients
D.F. Vollherbst, H. Lücking, J. DuPlessis, M. Sonnberger, C. Maurer, N. Kocer, M. Killer-Oberpfalzer, R. Rautio, L. Valvassori, A. Berlis, S. Gasser, S. Gatt, A. Dörfler, M. Bendszus, M.A. Möhlenbruch
American Journal of Neuroradiology Mar 2023, DOI: 10.3174/ajnr.A7834

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The FRESH Study: Treatment of Intracranial Aneurysms with the New FRED X Flow Diverter with Antithrombotic Surface Treatment Technology—First Multicenter Experience in 161 Patients
D.F. Vollherbst, H. Lücking, J. DuPlessis, M. Sonnberger, C. Maurer, N. Kocer, M. Killer-Oberpfalzer, R. Rautio, L. Valvassori, A. Berlis, S. Gasser, S. Gatt, A. Dörfler, M. Bendszus, M.A. Möhlenbruch
American Journal of Neuroradiology Mar 2023, DOI: 10.3174/ajnr.A7834
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